What will you do?
- Set up of QC labs and organization of QC teams, motivates employees towards achieving the objectives set
- Perform all duties according to current GMP regulations and other pharmaceutical regulations
- Preparation, reviewing and approval of procedures, instructions and other QC's documents
- Ensure the performance of all necessary tests and evaluation of related records
- Timely release or rejection of tested raw materials, packaging materials and intermediates, product in bulk and final product. Timely and reliable performance of analysis
- Ensure compliance with the HSE (health, safety and environment) requirements
- Participate and represent the company, both in internal and external audits.
- Ensuring the performance of all appropriate method transfers and validation
- Ensuring the maintenance and qualification of premises and equipment in department
- Participation and representation of the company in internal and external audits
- Management and supervision of stability studies
- Approval and monitoring of contract analysts and laboratories
What do we expect?
- Education background in Biochemistry, Biotechnology or related field, ideally Master or PhD level
- Practical and theoretical knowledge in transfer and validation of analytical methods, stability studies, analysis of biologic drugs, analysis of release raw materials, intermediates and final drug product
- At least 5 years’ experience in regulated laboratory environment (preferred biotechnological lab)
- Strong knowledge of GMP and GDP rules and ability to conduct them in laboratory and supervise compliance with these rules
- Very good abilities to organizing team's and own work and ability to work under time pressure
- Fluent in English, willing to learn Polish language
- Ability of analytical thinking